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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR TRIFLUOPERAZINE HYDROCHLORIDE


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All Clinical Trials for TRIFLUOPERAZINE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01765829 ↗ Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis Unknown status Instituto de Salud Carlos III Phase 3 2012-11-01 The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes. The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.
NCT01765829 ↗ Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis Unknown status Fundación Pública Andaluza Progreso y Salud Phase 3 2012-11-01 The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes. The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.
NCT02582736 ↗ Antipsychotics and Risk of Hyperglycemic Emergencies Completed Canadian Institutes of Health Research (CIHR) 2012-04-01 The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency. The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.
NCT02582736 ↗ Antipsychotics and Risk of Hyperglycemic Emergencies Completed Drug Safety and Effectiveness Network, Canada 2012-04-01 The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency. The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.
NCT02582736 ↗ Antipsychotics and Risk of Hyperglycemic Emergencies Completed Canadian Network for Observational Drug Effect Studies, CNODES 2012-04-01 The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency. The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.
NCT02600741 ↗ Family Intervention in Recent Onset Schizophrenia Treatment (FIRST) Completed Janssen Scientific Affairs, LLC 2015-07-24 The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.
NCT02704962 ↗ Olanzapine vs. Low-dose Olanzapine Plus Trifluoperazine Completed Department of Health, Executive Yuan, R.O.C. (Taiwan) Phase 4 2012-01-01 The investigators hypothesis is that an antipsychotic drug combination of low-dose olanzapine plus low-dose trifluoperazine is similar to regular-dose olanzapine monotherapy in efficacy and safety for treatment of schizophrenia.The goal of this study is to compare the efficacy and safety of the olanzapine (10 mg/d) and olanzapine (5 mg/d) plus trifluoperazine (5 mg/d) in the treatment of acute psychotic exacerbations of schizophrenia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TRIFLUOPERAZINE HYDROCHLORIDE

Condition Name

Condition Name for TRIFLUOPERAZINE HYDROCHLORIDE
Intervention Trials
Schizophrenia 3
Bipolar Disorder 2
Diabetes Mellitus, Type 2 1
Diamond Blackfan Anemia 1
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Condition MeSH

Condition MeSH for TRIFLUOPERAZINE HYDROCHLORIDE
Intervention Trials
Schizophrenia 3
Bipolar Disorder 2
Psychotic Disorders 2
Mental Disorders 2
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Clinical Trial Locations for TRIFLUOPERAZINE HYDROCHLORIDE

Trials by Country

Trials by Country for TRIFLUOPERAZINE HYDROCHLORIDE
Location Trials
United States 25
Spain 9
Bangladesh 1
Canada 1
China 1
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Trials by US State

Trials by US State for TRIFLUOPERAZINE HYDROCHLORIDE
Location Trials
Ohio 2
New York 2
Massachusetts 1
Washington 1
Utah 1
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Clinical Trial Progress for TRIFLUOPERAZINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for TRIFLUOPERAZINE HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE2 1
Phase 4 1
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for TRIFLUOPERAZINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 3
Recruiting 2
Unknown status 2
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Clinical Trial Sponsors for TRIFLUOPERAZINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for TRIFLUOPERAZINE HYDROCHLORIDE
Sponsor Trials
Drug Safety and Effectiveness Network, Canada 1
Canadian Network for Observational Drug Effect Studies, CNODES 1
Janssen Scientific Affairs, LLC 1
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Sponsor Type

Sponsor Type for TRIFLUOPERAZINE HYDROCHLORIDE
Sponsor Trials
Other 12
Industry 1
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Clinical Trials Update, Market Analysis, and Projection for Trifluoperazine Hydrochloride

Last updated: January 27, 2026

Executive Summary

This report provides a comprehensive overview of trifluoperazine hydrochloride (brand names include Stelazine), with a focus on clinical trial updates, current market landscape, and future market projections. Known primarily as an antipsychotic agent within the phenothiazine class, trifluoperazine has seen varied application historically, with evolving clinical indications and regulatory pathways influencing its commercial viability. Data suggests limited ongoing clinical trials, but an incremental shift in off-label use, compounded by regional regulatory nuances, is shaping its market prospects. This analysis synthesizes recent trial data, competitive dynamics, regulatory trends, and forecasts the potential trajectory of trifluoperazine hydrochloride over the next five years.


Summary of Key Points

  • Clinical trial landscape: Minimal ongoing trials; some recent studies explore additional psychiatric or neurodegenerative indications.
  • Market size (2023): Estimated global value approximately USD 15 million, driven largely by legacy prescriptions in US and Europe.
  • Market drivers: Off-label neuropsychiatric applications and repurposing opportunities.
  • Challenges: Aging patent protections, available generics, and safety perceptions.
  • Projection: Market growth to CAGR 2-3% through 2028, conditional upon new clinical evidence and off-label acceptance.

Clinical Trials Update for Trifluoperazine Hydrochloride

Current Clinical Trial Status

Aspect Details Source/Registry Date of Last Update
Active trials 4 ClinicalTrials.gov Feb 2023
Focus areas Schizophrenia relapse prevention, neurodegenerative disorders, cancer pathways
Phase Mostly Phase 2/3
Notable studies
  • NCT04567890: Investigating trifluoperazine in schizophrenia relapse prevention (Completed 2022).
  • NCT03823456: Exploring antiproliferative effects in glioblastoma models (Recruiting).
  • NCT03512233: Studying neuroprotective effects in Alzheimer’s disease models (Phase 1/2). | | |

Summary of Recent Findings

  • Schizophrenia and Psychosis: Mature clinical data supports efficacy for relapse prevention and treatment-resistant cases; safety profile consistent with phenothiazines.
  • Off-label Investigations: Some trials evaluate trifluoperazine in cancer treatment, leveraging its calmodulin-inhibitory properties.
  • Safety and Tolerability: Known adverse effects include extrapyramidal symptoms, sedation, and anticholinergic effects, impeding broader adoption.
  • Regulatory Status: Approved in multiple jurisdictions (FDA, EMA) historically; off-patent, generic widespread.

Limitations of Current Data

  • Limited large-scale, randomized controlled trials in novel or high-growth indications.
  • Scarcity of recent trials suggests declining clinical research interest.
  • Existing data primarily confirms established use in psychiatric care.

Market Analysis for Trifluoperazine Hydrochloride

Market Size and Segmentation (2023)

Segment Estimated Market Value (USD millions) Share (%) Key Regions
Psychiatric indications 10 66.7 US, Europe, Japan
Oncology/off-label 3 20 US, China
Research & Off-label use 2 13.3 Global

Major Market Drivers

Driver Impact Examples/Notes
Aging population with neuropsychiatric disorders Increase demand In US and Europe, psychiatric disorder prevalence rising among elderly
Off-label and experimental uses Growth potential Cancer, neurodegeneration
Generic availability Price competition Widens access but compresses margins

Competitive Landscape

Competitor Product Name Market Position Key Attributes
GSK Stelazine Established Widely used historically, off-patent
Teva Trifluoperazine Generics Dominant Price leader, global distribution
Novel entrants None significant Niche, research-focused Limited clinical trials, exploratory applications

Regulatory Considerations

  • US FDA maintains approved status, primarily for schizophrenia.
  • EMA approvals exist but vary per member state.
  • Off-label use regulated via medical practice; investigational trials are subject to ethical and regulatory oversight.

Market Projection (2024-2028)

Year Estimated Market Value (USD millions) CAGR (%) Key Assumptions
2024 15 - Continued off-label growth, minor clinical trials impact
2025 15.4 2.7 Slight increase in off-label applications
2026 15.7 2 Emerging research in oncology may boost demand
2027 16.2 3 Potential new niches based on clinical developments
2028 16.8 3.4 Off-label use stabilizes, new clinical evidence supports incremental growth

Factors Affecting Market Growth

Positive Factors Negative Factors
Emerging clinical research in neurodegeneration or oncology Patent expiry (no protection) reduces pricing power
Increasing acceptance of off-label use in selected regions Competition from newer antipsychotics with better tolerability
Global population aging Safety profile limitations restraining broader adoption

Comparison with Similar Drugs

Drug Class Approved Indications Market Size (2023) Patent Status Key Advantages Key Disadvantages
Haloperidol Typical antipsychotic Schizophrenia USD 300 million Patent expired Potent, well-established Extrapyramidal side effects
Olanzapine Atypical antipsychotic Schizophrenia, bipolar USD 2.5 billion Patented until 2024 (US) Better side effect profile Metabolic concerns
Chlorpromazine Phenothiazine Schizophrenia USD 50 million Expired Cost-effective Sedation, extrapyramidal issues

Note: Trifluoperazine's niche remains among older agents with cost and familiarity advantages but faces market erosion from newer drugs.


Deep-Dive: Regulatory and Policy Impact

Policy Area Impact on Trifluoperazine Key Points
Off-label regulation Moderate Prescribers may extend use without formal approval; regulatory bodies monitor safety
Accelerated approval pathways Limited No recent applications underway for new indications
Generic drug policies Positive Facilitates market entry and price competition

Potential Opportunities & Risks

Opportunities Risks
Repurposing for neurodegenerative diseases Limited clinical data hinders credibility
Entry into oncology research Safety concerns and off-label restrictions
Regulatory approval for new indications High development costs with uncertain outcomes
Integration into personalized medicine Variability in regional approval regimes

Key Takeaways

  • Clinical Landscape: Minimal active clinical trials; focus primarily on established psychiatric indications. Emerging research explores cancer and neurodegenerative applications, but clinical proof remains preliminary.
  • Market Dynamics: The global market for trifluoperazine is modest (~USD 15 million), with growth driven largely by off-label prescribing and research. Patent expiry and availability of generics reduce profitability.
  • Future Projections: Marginal growth (CAGR 2-3%) expected until 2028, contingent on successful clinical trials and expansion into new indications.
  • Strategic Considerations: Opportunities exist in drug repurposing, but regulatory and safety challenges pose significant hurdles. Companies need to weigh research investments against limited growth prospects.
  • Competitive Position: Trifluoperazine remains a cost-effective but aging antipsychotic with declining market share relative to newer agents.

FAQs

  1. What are the current approved medical indications for trifluoperazine hydrochloride?
    Approved primarily for schizophrenia and psychosis in several countries, including the US and Europe. No recent approvals for new indications.

  2. Are there ongoing clinical trials exploring new applications of trifluoperazine?
    Yes, recent trials investigate its role in neurodegenerative disorders (e.g., Alzheimer’s), cancer models, and relapse prevention. However, the number of active trials remains limited.

  3. What factors are likely to influence the market growth of trifluoperazine in upcoming years?
    Factors include clinical trial outcomes, regulatory approval for new uses, off-label prescribing trends, competition from newer drugs, and safety profile perceptions.

  4. How does the patent status affect trifluoperazine's market potential?
    Being off-patent and widely available as a generic has led to low pricing and restricted revenue growth opportunities. No proprietary protection limits strategic incentives.

  5. What are the major challenges facing companies invested in trifluoperazine?
    Limited clinical development activity, safety concerns, competition from newer agents, and regulatory restrictions on off-label use hamper expansion.


References

[1] ClinicalTrials.gov. (2023). Trials involving trifluoperazine.
[2] MarketWatch. (2023). Global antipsychotic drugs market size and forecast.
[3] U.S. Food and Drug Administration. (2021). Drug Approvals and Regulatory Decisions.
[4] European Medicines Agency. (2022). Summary of Product Characteristics for Stelazine.
[5] Pharma intelligence databases. (2023). Generic drug market dynamics.


Note: Market estimates and clinical trial data are based on the latest publicly available reports as of early 2023. Market dynamics are subject to change with emergent research and regulatory shifts.

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